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FDA 510(k)

SUGAR CHEX ONE

K-Number: K001443 · 2000-06-29

ApplicantStreck Laboratories, Inc.
Decision Date2000-06-29
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SUGAR CHEX ONE is the device name listed in this FDA 510(k) record. The listed applicant is Streck Laboratories, Inc.. It received FDA 510(k) clearance on 2000-06-29 under 510(k) number K001443. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUGAR CHEX ONE?

SUGAR CHEX ONE is a medical device that received FDA 510(k) clearance on 2000-06-29. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K001443.

When did SUGAR CHEX ONE receive FDA 510(k) clearance?

SUGAR CHEX ONE received FDA 510(k) clearance on 2000-06-29, under 510(k) number K001443.

Who is the listed applicant for SUGAR CHEX ONE?

The FDA 510(k) record lists Streck Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUGAR CHEX ONE?

The FDA product code for SUGAR CHEX ONE is JJX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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